MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number TJF-Q190V

Device Problems Break (1069); Material Rupture (1546); Device Damaged by Another Device (2915); Difficult to Advance (2920); Mechanical Jam (2983); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/29/2022

Event Type  Injury  

Event Description

The customer reports during an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenoscope with a single use distal cover and a single use extraction balloon, the distal cover split open during the procedure and several devices broke because of it.It was observed that bioburden had gotten lodged behind the elevator of the scope.The elevator could not fully function in its range of motion, could not go fully up and down.At first, the customer noticed that the device (scope/distal cover) was not able to pass smoothly through the channel, and the physician observed that he was not able to fully open or close the elevator.The elevator jammed at 45 degrees angle and was not able to fully open.When passing devices, the physician ended up stripping and breaking some of the devices.An extraction balloon that was broken up inside the patient's duct and they had to take scope out and go retrieve it.Once retrieved, the physician to use a different balloon and it started to break because could not fully open elevator, it felt jammed.The physician placed a stent.After barely placing the stent, they finished the procedure.The physician took scope out and realized cap was completely split at the top, and there was a lot of bio burden back behind the elevator causing it to not fully open and close.There were no procedural or anatomical challenges that could have contributed to the distal cover splitting.The lot number cannot be provided for the distal cover used.The scope is not being returned to olympus for repair.Once the scope was cleaned, the scope was found to be in working order.The elevator was moving without issue.The physician was successful in sweeping the stones, but the balloon popped due to sharp stone edges.Another balloon ripped before inserting it into duct.In hindsight, the elevator was not moving appropriately due to sludge and stone jamming behind the elevator channel.This was not known at the time of the procedure.A non-olympus retrieval device was used to extract the balloon from the patient¿s duct.It was observed that the balloon was stretching inappropriately.There were no adverse effects to the patient as a result of this occurrence.The procedure was completed.The patient¿s current condition is reported as discharged home in stable condition.Case with patient identifier (b)(6) reports the b-v243q-a.Case with patient identifier (b)(6) reports the tjf-q190v.Case with patient identifier (b)(6) reports the maj-2315.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 15128736
• MDR Text Key: 296854480
• Report Number: 2429304-2022-00009
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2022,07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Device Catalogue Number: N5992941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 76 KG